Kornimate/medical-research-clean huggingface dataset:
corevalve evolut pro prospective registry

Conditions: Aortic Stenosis

Summary: the primary objective of this study is to evaluate the real-world performance of the corevalve evolut pro transcatheter aortic valve, including leaflet function, in a prospective observational registry.

the corevalve evolut pro transcatheter aortic valve was approved by the fda in march 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in july 2017 for intermediate risk patients. this latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak. in this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the corevalve evolut pro will be prospectively collected into a registry database. the institutional heart team will select patients according to standard practice.

Eligibility criteria:
inclusion criteria: 1. symptomatic severe aortic stenosis 2. intermediate, high or extreme surgical risk 3. the institutional heart team determines that transcatheter aortic valve replacement with an evolut pro device is appropriate exclusion criteria: 1. subject unable or unwilling to give informed consent 2. for subjects in the ct arm only, renal function precluding the administration of iodinated contrast for cardiac ct (egfr \< 30 ml/min/1.73m2). an exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media. 3. pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
seasonal affective disorder and visual impairment

Conditions: Seasonal Affective Disorder; Visual Impairment

Summary: as a subtype of major depressive disorder, seasonal affective disorder (sad) or winter depression causes severe reductions in both quality of life and productivity and results in high morbidity and frequent sick leave (1). sad is a prevalent disorder with rates as high as 3-5% in central european countries and 8-10% in scandinavian countries. in our recent screening survey among persons with severe visual impairment or blindness (visual acuity \< 6/60), we found a strikingly high prevalence of sad of 17 % compared to 8% in the fully sighted control group. persons with maintained light perception had a highly increased sad prevalence of 18 % whereas no light perception (nlp) respondents had an sad prevalence of 13 %. light is unquestionably of great importance in the development and treatment of sad. it is suggested that a reduced retinal sensitivity to light leads to sub-threshold light input to the brain and consequently to the development of sad. the novel retinal non-visual photoreceptors, the intrinsically photosensitive retinal ganglion cells (iprgcs), are involved in the regulation of circadian rhythm and mood and their function are in part independent of the function of the classical rod and cone photoreceptors which form the basis of conscious visual perception. function of the iprgcs can be assessed by chromatic pupillometry where the sustained pupillary contractions following blue light stimulation (pipr) is the main outcome. in persons with sad without eye disorder the function of the iprgcs is reduced. we here wish to investigate associations between iprgc function and sad symptoms, circadian profile and treatment response to light therapy in persons with visual impairment. persons with visual impairment (sad and non-sad) are assessed for iprgc function with chromatic pupillometry, for seasonal mood variation by interview and questionnaire and for diurnal melatonin secretion by saliva analysis summer and winter. in winter sad participants are treated with daily morning bright light for 6 weeks. reduction in depression scores and tolerability is recorded.


Eligibility criteria:
inclusion criteria: seasonal affective disorder. visual impairment (snellen visual acuity \< 6/18) or visual field reduction (md\<10). exclusion criteria: alcohol or drug abuse. current or planned pregnancy. other neuropsychiatric disorder. antidepressant medication. regular use of melatonin.

Keywords: pupillometry light therapy visual impairment melatonin iprgc
comparison of different fluence settings for yellow subthreshold laser treatment in diabetic macular edema

Conditions: Diabetic Retinopathy

Summary: to assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (dc)) compared to standard etdrs (early treatment of diabetic retinopathy study) continuous wave (cw) laser

test burn up to barely visible burn with micropulse laser, then reduce the power by 70% and perform laser with various dc (5%, 15%, cw) as per the group. focal to mas+ confluent burns to areas of diffuse leakage

Eligibility criteria:
inclusion criteria: * eyes with dme (center or non-center involving) with \<350 microns central retinal thickness exclusion criteria: * subfoveal exudates, history of vr surgery, history of macular laser
delayed or direct ureteroscopy in the treatment of pediatric calcular anuria

Conditions: Acute Renal Failure; Anuria; Obstructive Uropathy; Ureteric Stones

Summary: to compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure in children.

to compare staged ureteroscopy following initial urinary drainage and stabilization of renal functions using percutaneous nephrostomy or double j stent versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure due to ureteric calculi in children.

Eligibility criteria:
inclusion criteria: * children ≤12 years old presenting with obstructive anuria and acute renal failure due to bilateral ureteric stones suitable for ureteroscopy. exclusion criteria: * fever, pyonephrosis or sepsis. * unstable patients are stabilized first by dialysis.

Keywords: anuria children ureteroscopy initial urinary drainage ureteric stones
romanian national registry of outcomes after transcatheter aortic valve implantation in patients with severe aortic stenosis - ro-tavi

Conditions: Aortic Stenosis Symptomatic; Aortic Valve Stenosis

Summary: ro-tavi is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (tavi) to assess patient care and outcomes.

background: since the establishment of transcatheter aortic valve implantation (tavi) in romania in 2015 there has been a growing number of interventions being performed by an increasing number of hospitals throughout the country. in 2018, there were more than 250 implants, which are expected to grow in the following years by about 30% on an annual basis. objective: this is a national quality assurance initiative to improve patient care and outcomes. it further serves as a database for the assessment of the safety and efficacy of tavi and its financial implications (e.g. reimbursement). design: national, prospective, observational, multi-center registry. all centers performing tavi in romania; minimum cases per center for inclusion: 20 cases/year-to-date population: all patients undergoing tavi in romania at any of the participating centers with a ce-marked valve of any manufacturer given that they provide written informed consent.

Eligibility criteria:
inclusion criteria: * severe symptomatic aortic valve stenosis * high risk or patients deemed amenable for tavi by a multidisciplinary team * signed informed consent to participate in the study exclusion criteria: * inadequate annulus size (\ 29 mm) * left ventricle thrombus * active endocarditis * high risk of coronary ostium obstruction * plaques with mobile thrombi in the ascending aorta, or arch * hemodynamic instability * estimated life expectancy \<1 year * comorbidity suggesting lack of improvement of quality of life * other situations adjudicated by the local heartteam

Keywords: aortic stenosis
using herbs and spices to increase children's acceptance and intake of vegetables in school lunches

Conditions: Pediatric Obesity

Summary: herbs and spices offer one potential solution to the recent decline in children taking school lunch because they can increase the palatability of foods without adding salt and fat. however, there is currently limited evidence on how to successfully integrate herbs and spices into the school lunch menu. developing evidence-based methods to teach school cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs and spices is a research priority. the investigators hypothesize that herbs and spices can be used to increase acceptance, intake, and participation in the school lunch program among 6th - 12th grade students from central pennsylvania.

what this study will add to the literature: herbs and spices offer one potential solution to the recent decline in children taking school lunch because they can increase the palatability of foods without adding salt and fat. however, there is currently limited evidence on how to successfully integrate herbs and spices into the school lunch menu. developing evidence-based methods to teach school cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs and spices is a research priority. this research will provide evidence that herbs and spices can be used to increase acceptance, intake, and participation in the school lunch program among 6th - 12th grade students from central pennsylvania.

Eligibility criteria:
inclusion criteria: * student in bald eagle area middle/high school * parents of students in bald eagle area middle/high school * school food service employees at the bald eagle area middle/high school exclusion criteria: * students/children who have food allergies to herb/spice blend ingredients.
evaluation of txa prior to surgery in the geriatric hip fracture population

Conditions: Hip Fractures

Summary: the overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.

a significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. these patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. however, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population. tranexamic acid (txa) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of txa prior to the procedure to decrease the risk of blood loss. thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions. the investigators will examine if administration of txa prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent 2. age \> or = to 65 years 3. hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions 4. indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation exclusion criteria: 1. indication for closed reduction or percutaneous screw 2. allergy to txa 3. cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture 4. presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin iii, factor v leiden, protein s \& c deficiencies, prothrombin gene mutation)

Keywords: blood transfusion hip fracture surgery replacement trauma
pain control in colorectal surgery: liposomal bupivacaine block versus intravenous lidociane

Conditions: Colorectal Disorders

Summary: to compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine tap block in colorectal surgery. this is to be integrated into the standard eras protocol currently utilized at carolinas medical center. primary endpoints will be postoperative pain as measured by verbal rate scale (vrs), postoperative morphine equivalents utilized per day, and over 30 days. secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and pacu), post-operative morbidity (clavien-dindo, related to both anesthesia and surgery), cost of hospitalization (operative, pacu, postoperative stay, and total) and quality of life on follow up.


Eligibility criteria:
inclusion criteria: * age 18-75 years * elective laparoscopic colorectal surgery * asa i-iii exclusion criteria: * contraindication to na channel blocker * chronic opioid use * liver dysfunction * renal insufficiency * epilepsy * psychomotor retardation * bmi \>40 * sleep apnea * cardiac rhythm disorders * planned open or concomitant procedure
evaluation of fosaprepitant (mk0517) in single dose schedule (0517-017)

Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)

Summary: the purpose of this study is to examine the safety, tolerability, and efficacy of mk0517 to prevent chemotherapy-induced nausea and vomiting (cinv) associated with cisplatin chemotherapy.


Eligibility criteria:
inclusion criteria: * patient is male or female and is at least 18 years of age; scheduled to receive his or her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted life expectancy of 3 months or greater * patient is post menopausal or, if premenopausal, must use double-barrier contraception exclusion criteria: * patient has symptomatic primary or metastatic cns malignancy * patient has received or will receive radiation therapy to the abdomen or pelvis in the week prior to treatment day 1 though day 6 * patient has vomited in the 24 hours prior to treatment day 1 * patient has an active infection; patient uses illicit drugs or has current evidence of alcohol abuse * patient is pregnant or breast feeding
e. coli nissle 1917 - suspension for infection prophylaxis

Conditions: Infections

Summary: this study evaluates the long term effects of e. coli strain nissle 1917 (ecn-suspension) probiotic bacteria administration on the number of both, bacterial and viral infections during the first 24 months of infant's life. half of study participants will receive ecn-suspension, while the other half will receive placebo. in an additional non-clinical explorative evaluation will furthermore be investigated whether the early intestinal colonization with e.coli strain nissle 1917 affects the establishment of the intestinal microbiota.

in the course of the present trial the participants will be observed during the first 24 months of life, starting right after birth. all newborns meeting all inclusion criteria and non-fulfilling any exclusion criteria will be included into the trial. each participant of this clinical trial will be randomly allocated to one of the two trial arms, by using the method of randomly permuted blocks. the newborns will be primarily treated during the first three weeks of life and re-treated after 6 and 12 months according to trial interventional plan. data on the efficacy and safety will be recorded during control visits after first month, 6, 12, 18 and 24 months. a follow-up examination of study participants will be performed two years after the end of the participation in the present trial (i.e. at an age of 48 months), during which each child will be examined for its normal physical and cognitive development (covered by the u8 standardized examination). in addition data on allergic/atopic complaints or symptoms will be recorded. in an additional non-clinical explorative evaluation, it will furthermore be investigated whether the early intestinal colonization with e.coli strain nissle 1917 affects the establishment of the intestinal microbiota. therefore stool samples of study participants will be collected at an age of 24 and 48 months. the microbial composition of these samples will be characterized and compared between the two trial arms (ecn vs. placebo).

Eligibility criteria:
inclusion criteria: * signed informed consent form by the parents * age at inclusion: max. 120 hours after birth * functionally mature infant * gestational age more than 35th week of development * mother's intention to breastfeed the participant * readiness of the mother to administer no probiotics additionally to the trial medication exclusion criteria: * non-fulfilment of the at least one inclusion criteria * lack of propensity/compliance of mother * 5 min apgar score less than 5 * 10 min apgar score less than 8 * ph of umbilical cord blood less than 7 (determination not obligatory, if apgar scores do not indicate that the child may have suffered from a perinatal asphyxia) * any perinatal infection required antibiotic treatment * birth weight less than 2000 g * torch-infection of the mother * hiv-infection of the mother * any severe medical condition of mother or newborn which in the opinion of the investigator may have a critical impact on the conduct of the study.
radiofrequency denervation for reducing chronic pain: a meta-analysis

Conditions: Chronic Neck Pain; Chronic Low Back Pain

Summary: the meta-analysis of data obtained from randomized controlled trial on effectiveness of radiofrequency denervation on reducing chronic neck and low back pain.


Eligibility criteria:
inclusion criteria: * rcts with pain vas as outcome exclusion criteria: * none
buccal prochlorperazine versus intravenous prochlorperazine for migraine headaches, a rct

Conditions: Migraine Disorders

Summary: headache is a common presenting complaint to the emergency department accounting for 1-2% of patient visits. of these headaches, approximately 90% are migraine, tension headache, or combined presentations. the most commonly used migraine therapy in the ed is intravenous prochlorperazine, but its administration requires close nursing observation, a bed, and the insertion of an intravenous catheter. buccal prochlorperazine represents an alternative form of delivery that enables rapid achievement of therapeutic blood levels and may lead to symptom resolution. in a randomized, controlled, prospective study,the investigators plan to assess the efficacy of buccal versus intravenous prochlorperazine for the initial emergency department treatment of migraine headaches.


Eligibility criteria:
inclusion criteria: * patients between 18-65 years of age evaluated in the emergency department at harbor-ucla with migraine headache as defined by the headache classification committee of the international headache society. (patients must have had at least one prior similar headache, with or without nausea, vomiting, aura, photophobia, or phonophobia). * only subjects able to consent to treatment will be included. exclusion criteria: patients with the following conditions: * pregnancy * breastfeeding * fever greater or equal to 100.4 degrees * diastolic blood pressure of 105 or higher * altered mental status * meningeal signs * suspicion for intracranial process requiring further investigation * known allergy to prochlorperazine * the use of ergotamines, antiemetics, antipsychotics or sedatives in the previous 24 hours of study entry.
pre-washing the catheter with a culture medium before intrauterine insemination

Conditions: Infertility

Summary: the aim of the study to evaluate the possible effect of washing the insemination catheters before intrauterine insemination on the pregnancy outcomes. we know that washing the catheters are already washed in the case of embryo transfer for assisted reproductive techniques. based on this knowledge, we also constituted the hypothesis which is about the impact of washing the catheter on the gametes and embryos. the pre-washing the catheter before intrauterine insemination may provide higher pregnancy results.


Eligibility criteria:
inclusion criteria: * at least 1-year infertility * at least one patent fallopian tube confirmed by hysterosalpingography (hsg) or laparoscopy * ovulatory menstrual cycles * suitable semen analysis according to the world health organization (who) criteria for intrauterine insemination exclusion criteria: * bilateral tubal occlusion * mild or severe endometriosis * day 3 serum fsh (follicle-stimulating hormone) \> 13 iu/l * abnormal thyroid function tests, hyperprolactinemia * total motile sperm count (tmsc) \< 5 millions or severe teratospermia (\<4% normal forms) following semen preparation * more than 3 follicles above the size of 17mm on the day of ovulation triggering

Keywords: intrauterine insemination, pre-washing catheter
new physitherapy or alternative therapy for hiccup

Conditions: Hiccup

Summary: hiccup is a common symptom, and it is currently believed that hiccups result from diaphragmatic spasm, with onset ranging from minutes to days. some patients may terminate on their own, or by ways such as gasping. for some patients with duration longer than 1 day, even longer than 2 days, medications may be needed, mainly: metoclopramide, eperisone hydrochloride tablets, etc. acupuncture is also effective for some patients. surgical treatment may be required for some clinically intractable hiccups. however, for the above interventions or treatment means, the current efficacy still needs to be improved. in the previous clinical experience, we create a new physical clinic protocol which could terminate the hiccup symptom onset instantaneously without adding extra cost to the patient, and the physiotherapy method was convenient and effective. to further validate the superiority, safety of this novel physical therapy regimen, we designed a randomised controlled, prospective, single centre clinical study aimed at comparing the efficacy and safety of the novel physical therapy with conventional pharmacotherapy in patients with hiccups.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * able to swallow water exclusion criteria: * allergy or contraindication to the following drugs: metoclopramide et al * severe choking on water and difficulty swallowing were present * impaired consciousness and inability to cooperate

Keywords: hiccup